Xiaohai Li Email & Phone Number

Jupiter, Fl, Us

Boston, Massachusetts, United States

• Identify and implement appropriate assays and technologies relevant to ADME-DMPK characterization for assessment of small molecule therapeutics for the drug discovery portfolio.• Responsible for Discovery ADME study design, data analysis, PK/PD modeling & simulation and prediction.• Integrate, interpret and report data to project teams and management.• Initiate and facilitate collaboration with preclinical stakeholders for all DMPK/ADME projects.• Characterize routes of metabolism in vitro and in vivo.• Implement strategy and execution of non-clinical studies to identify DDI risks.• Support BD in evaluating potential drug pipeline assets by thorough and complete due diligence.- Extensive experience in the pharmaceutical industry focused on DMPK in neurodisorders and cancer therapeutic areas. - In depth in vitro and in vivo ADME and pharmacokinetics knowledge and proven scientific expertise in problem solving and integrating multi- functional data in support of discovery projects.

Marvern, Pa

Specialized on bioanalytical and analytical method development including regulated LC-MS based bioanalysis, challenging analytical method trouble-shooting, and non-GLP discovery bioanalytical quantifications;Well trained and solid experience on GLP compliance, support assay method protocol and smooth transitions to method validation;Expertise in assessment and implementation of new bioanalytical technologies for bioanalytical assaysServe as an expert on LCMS based assays, providing technical support, as needed to internal and external laboratories working to implement assays. Communicate results in presentations to stakeholders in partner organizations or at external scientific meetings, to write technical reports, and to participate on cross-functional teams. Mentor instrument operators and junior scientists about the instrument’s operation and maintenance and method developments issues.Expertise on method development in analysis of chiral compounds, polar oligo-glycans, protein or peptides biomarkers, prodrugs, lipid-drug conjugates, and small molecular drugs etc;CRO experience with various instrumentation such as LC/MS, LC/MS/MS from Agilent, Waters, Shimadzu, Applied Biosystem; HPLC-UV, prep-HPLC from Agilent, Waters, Shimadzu. Strong LC-MS/MS, HPLC, related troubleshooting skills;Expertise in in vitro drug metabolism assays to evaluate drug candidates drug-like properties, experienced in drug metabolites and bioactivation profiling studies;In total, over twenty five projects were independently completed and moved into GLP regulated method validation, which included challenging and difficult analytes with variable properties such as oligo-glycans Dekaparin, protein biomarkers, peptides drug candidates, lipid drug conjugate et cl.

Jupiter, Fl, Usa

Research focuses on the mechanism of biotransformation particularly the mechanism of the formation of reactive metabolites by P450 or non-P450 enzymes, P450 mediated drug metabolism, enzymatic kinetics, P450 inhibition, in vitro and in vivo metabolite profiling and structure elucidation, and early screen and identification of bioactivation liabilities of NCEs.Established and optimized the high throughput qualitative methods for screening the potential reactive metabolites from drug candidates in vitro and in vivo.Examined structure-bioactivation relationships and liabilities of compounds including assessment and characterization of bioactivation pathways of drugs and new chemical entities (NCEs) and evaluation of the underlying mechanisms leading to CYP enzyme inhibition and drug-drug interactions.Firstly discovered the bioactivation mechanisms of some clinically important drugs, such as Dasatinib, Erlotinib, Gefitinib and quetiapine which were proposed to link with their rare but serious toxicities;Discovered the first highly selective inhibitor SR9186 by efficiently collaborating with medicinal chemists.Identified and characterized the potential specific probe substrate reaction for differentiating the contribution of CYP3A4 and CYP3A5 in the metabolism of drug and xenobiotics.Have worked on couple collaboration research projects, mainly focusing on developing and optimizing LC-MS/MS based bio-analytical methods for small molecular drug candidates, endogenous metabolites and also antibody drug conjugates.

Research focuses on the mechanism of biotransformation particularly the mechanism of the formation of reactive metabolites by P450 or non-P450 enzymes, P450 mediated drug metabolism, enzymatic kinetics, P450 inhibition, in vitro and in vivo metabolite profiling and structure elucidation, and early screen and identification of bioactivation liabilities of NCEs.Established and optimized the high throughput qualitative methods for screening the potential reactive metabolites from drug candidates in vitro and in vivo.Examined structure-bioactivation relationships and liabilities of compounds including assessment and characterization of bioactivation pathways of drugs and new chemical entities (NCEs) and evaluation of the underlying mechanisms leading to CYP enzyme inhibition and drug-drug interactions.Work on establishing proteomics-based strategies to identify and characterize drugs or chemicals chemically modified proteins; Therefore mechanism of bioactivation-mediated drug toxicities could be explained from the perspective of the significant roles of damaged protein targets.Develop the bioanalytical methods to characterize the preoccupation level of human hepatocytes in humanized mice model;

Los Angeles, Ca, Usa

Set up proteomics core lab and developed the Nano-RP/HPLC -based mass spectrometry approaches for identification of proteins and their PTMs from biosamples, such as tissue samples and prefractionated subproteome samples;- employed protein chemistry, protein fractionation and electrophoresis, advanced mass spectrometry analysis and bioinformatics to support biomedical proteomic researchIndependent projects include:- extensively identified the 20S proteasome subunits and their PTMs; examined the purified murine heart mitochondrial proteins;- developed and optimized the strategy of combining multi-proteases protein digestion with Nano-RP-HPLC-MS/MS method for protein identification and their PTMs;

Beijing, China

Research fellow in Prof. Xiaohong Qian's Lab; participated in the international research project- plasma proteome project launched by HUPO (international human proteome organization).- driving force in establishing and optimizing the sample preparation methods, including the high abundant plasma protein affinity depletion methods; and intact plasma proteins pre-fractionation methods by multidimensional chromatography such as the anion exchange chromatography and RP-HPLC; or gel-based separation approaches, such as SDS-PAGE and 2DE; established the shotgun strategy for identifying the proteins in human serum or plasma- established and compared alternative analytical techniques for the characterization of the human serum proteome; proposed research plan which was awarded by the HUPO PPP funding (Ref. No. PPP-SP/04-12 )

Hebei, China

As a quality control analyst, I developed and optimized HPLC-based analytical methods or protocols for quantitative analysis of raw chemical materials, intermediate products and final drug productsRecognized and promoted for being in charge of instrumental related quality control analysis in the dept. of quality control

Ph.D., Drug Metabolism And Pharmaceutical Analysis

M.Sc., Medicinal Chemistry

B.S., Pharmaceutical Science